Status: Finalised First registered on: 31/01/2023
Last updated on: 28/03/2023
1. Study identification
EU PAS Register NumberEUPAS50789
Official titleDARWIN EU® - Drug utilisation of valproate-containing medicinal products in women of childbearing potential
Study title acronym
Study typeObservational study
Brief description of the studyValproic acid/valproate-containing medicines are first-line treatment for epilepsy, and used as second-line treatments for the treatment of bipolar disorder and migraine prevention. Valproic acid/valproate is a teratogen, with prenatal exposure carrying a substantial risk of neurodevelopmental impairment and congenital malformations in the child. Therefore, its use in women of childbearing age is restricted to prevent valproate exposure during conception and pregnancy. The European Medicines Agency commissioned this DARWIN EU© study to estimate the incidence rate and prevalence of VPA use and alternative treatments, and to characterise patient-level valproate use in women between aged ≥12 to ≤55 12 and 55 years of age from 2010 to 2022.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU CC
Centre locationRotterdam, Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Jodicke
First name Annika
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

IDIAPJGol
Health Data Science
IQVIA
Oxford University, UK
Auria Clinical Informatics, Hospital District of Southwest Finland, Finland
Countries in which this study is being conducted
International study

Belgium
Finland
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/07/202226/07/2022
Start date of data collection01/01/201201/01/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report17/01/202317/01/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeEU funding scheme100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Jodicke
First name Annika
Address line 1University of Oxford
Address line 2Windmill Road 
Address line 3Headington 
CityOxford 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)441865223725 
Alternative phone number 
Fax number (incl. country code) 
Email address annika.jodicke@ndorms.ox.ac.uk
Public Enquiries
Title Dr 
Last name Jödicke 
First name Annika 
Address line 1University of Oxford 
Address line 2Windmill Road 
Address line 3Headington 
CityOxford 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)441865223725 
Alternative phone number 
Fax number (incl. country code) 
Email address annika.jodicke@ndorms.ox.ac.uk 
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